FDA inspection
Mevion Medical Systems, Inc.: FDA inspection ending Oct 9, 2024
FDA inspection 1251608 · Littleton, MA
Key facts
| Inspection ID | 1251608 |
|---|---|
| Firm | Mevion Medical Systems, Inc. |
| FEI number | 3007087027 |
| Address | 300 Foster St |
| City | Littleton |
| State | MA |
| ZIP | 01460-2017 |
| Fiscal year | 2025 |
| Inspection end date | Oct 9, 2024 |
| Project area | Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority|Postmarket Assurance: Medical Devices|Radiation Control and Health Safety Act (RCHSA) Authority |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data